Clinical Benefit of SAR650984 Bortezomib Lenalidomide and Dexamethasone Combination in NDMM Patients Not Eligible for Transplant

Brief description of study

Primary Objective:

To demonstrate the benefit of isatuximab (I) in combination with bortezomib (V), lenalidomide
(R) and dexamethasone (d) in the prolongation of progression free survival (PFS) as compared
with bortezomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple
myeloma (NDMM) not eligible for transplant.

Secondary Objectives:

To evaluate in both randomized arms: very good partial response (VGPR) or better rate as
defined by the International Myeloma Working Group (IMWG) criteria, minimal residual
disease (MRD) negativity rate in patients with complete response (CR) or VGPR, CR rate
per IMWG criteria, time to progression (TTP) and overall by MRD status, PFS in MRD
negative patients, duration of response (DOR) and overall by MRD status, time to first
response (TT1R), PFS on next line of therapy (PFS2), overall survival (OS), overall
response rate (ORR) (including crossover arm) per IMWG criteria (including crossover
arm), safety (including crossover arm), and to assess disease-specific and generic
health-related quality of life (HRQL)

To determine the pharmacokinetic (PK) profile of isatuximab in combination with
bortezomib, lenalidomide, and dexamethasone (excluding crossover arm)

To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (including
crossover arm)

Detailed Study Description

The duration of the study for each patient will include a screening period of up to 4 weeks,
an induction period of 24 weeks (4 cycles with a duration of 42 4 days), a continuous
treatment period and a crossover period (when applicable). The cycle duration is 28 4 days
during the continuous treatment and crossover periods.